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Kidney Week

Abstract: PO2612

Effects of Veverimer on Serum Bicarbonate and Physical Function in Women with CKD: A Subgroup Analysis from a Randomized Controlled Trial

Session Information

Category: Women’s Health and Kidney Diseases

  • 2000 Women’s Health and Kidney Diseases

Authors

  • Mathur, Vandana S., MathurConsulting, Woodside, California, United States
  • Wesson, Donald E., Baylor Scott & White Health and Wellness Center, Dallas, Texas, United States
  • Tangri, Navdeep, University of Manitoba, Winnipeg, Manitoba, Canada
  • Stasiv, Yuri, Tricida, Inc., South San Francisco, California, United States
  • Parsell, Dawn, Tricida, Inc., South San Francisco, California, United States
  • Li, Elizabeth, PharmaStat LLC, Fremont, California, United States
  • Klaerner, Gerrit, Tricida, Inc., South San Francisco, California, United States
  • Bushinsky, David A., University of Rochester Medical Center, Rochester, New York, United States
Background

More women than men have CKD. However, women have been under-represented in clinical trials.

Veverimer is an orally administered, non-absorbed polymer that treats metabolic acidosis by binding and removing HCl from the GI tract. In Phase 3 randomized, double-blind, placebo-controlled trials, veverimer significantly increased serum bicarbonate and improved physical function in acidotic patients with CKD (Wesson et al. Lancet, 2019). Here we analyzed efficacy and safety among the women in these studies of up to one year.

Methods

Physical function was assessed using the Kidney Disease and Quality of Life Physical Function Domain (KDQOL-PFD) which quantifies limitations on daily activities and by performance on the repeated chair stand (RCS) test.

Results

Of the 217 pts randomized, 83 (32%) were women, of whom 81% were post-menopausal (≥55 yrs). Select comorbidities included hypertension (95%), diabetes (64%), and congestive heart failure (30%). At Baseline, mean eGFR in women was 28.4 mL/min/1.73m2 and mean serum bicarbonate was 17.3 mEq/L.

More women receiving veverimer met the primary study endpoint, had a significant increase in serum bicarbonate and improved both KDQOL-PFD scores and RCS time (Table) compared with placebo. The effects of veverimer exceeded the minimal clinically important difference for both KDQOL-PFD (+3 to +5 points) and RCS (-1.7 seconds). Rates of serious, non-serious and GI adverse events were similar in the groups; none required treatment discontinuation.

Conclusion

Given their lower bone and muscle mass, women with CKD may be particularly vulnerable to the adverse effects of metabolic acidosis. We found that in women with CKD and metabolic acidosis, treatment with veverimer significantly improved how women felt and functioned. The safety of veverimer was similar to placebo.

Efficacy EndpointsPlacebo
(N = 33)
Veverimer
(N = 50)
Primary Endpoint: proportion increasing serum bicarbonate by ≥ 4 mEq/L or achieving normalization at Week 1228%63%
P<0.0001
Change from baseline in Serum Bicarbonate
(LS mean, mEq/L) at Week 12
+2.0+4.9
P< 0.0001
Patient-Reported Physical Function
(KDQOL-PFD Mean [SD] Total Score at Week 52)*
-5.16 (20.27)+13.15 (26.11)
P = 0.0031
Objective Measurement of Physical Function
(Mean (SD) Repeated Chair Stand Time at Week 52, seconds)*
+0.77 (1.68)-4.16 (15.43)
P = 0.0002

P-values are vs. placebo; An ANCOVA rank-based method was used for physical function endpoints *Based on evaluable patients enrolled in controlled extension study (placebo, n=31; veverimer, n=46)

Funding

  • Commercial Support